IRCT20200105046010N97 IRCT 2024-02-21 Kharazmi Pharmaceutical Co Bioequivalence Study of Empagliflozin/Linagliptin 25/5 mg Kharazmi Pharma Co In-vivo Bioequivalence Study of Empagliflozin/Linagliptin 25/5 mg Kharazmi Pharma Co Tablets of The Test Drug in Compared with The Reference Drug (GLYXAMBI® Tab 25/5 mg. Beohringer Ingelheim Germany) In Healthy Volunteers 2024-04-20 anticipated 24 Complete https://irct.ir/trial/75532 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: En Each candidate is assigned a number from 1 to 24. The numbers are written on a plastic ball, poured into a container, and mixed. The balls are then removed randomly from the container and divided in 2 groups of 12 test (A) and reference (B) drug recipients, then in the second phase, groups A and B will be cross-referenced to the test and drug recipients, Blinding description: This study is a single-blinded clinical trial (volunteers). Test and Originator brand's tablets are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form. Bioequivalence This study is performed on healthy volunteers and drug concentration in plasma is determined.. Intervention 1: Intervention group: single dose, one oral tablet GLYXAMBI® 25/5 mg manufactured by Boehringer as a reference product. after washout period, the volunteers receive Empagliflozin/Linagliptin 25/5 mg Kharazmi Pharma Co. Intervention 2: Intervention group: Single dose, one oral Empagliflozin/Linagliptin 25/5 mg Kharazmi Pharma Co as test product. after washout period, the volunteers receive GLYXAMBI® Tab 25/5 mg Boehringer Ingelheim Germany. No - There is not a plan to make this available Justification or reason for not sharing IPD is En These data are as secure between researchers and related industries.